EA201792329A1 - METHOD OF MONOMERIZATION OF RECOMBINANT ANTIBODY MOLECULES - Google Patents

METHOD OF MONOMERIZATION OF RECOMBINANT ANTIBODY MOLECULES

Info

Publication number
EA201792329A1
EA201792329A1 EA201792329A EA201792329A EA201792329A1 EA 201792329 A1 EA201792329 A1 EA 201792329A1 EA 201792329 A EA201792329 A EA 201792329A EA 201792329 A EA201792329 A EA 201792329A EA 201792329 A1 EA201792329 A1 EA 201792329A1
Authority
EA
Eurasian Patent Office
Prior art keywords
antibody molecules
monomerization
recombinant antibody
composition
reducing agent
Prior art date
Application number
EA201792329A
Other languages
Russian (ru)
Inventor
Сэм Филип Хейвуд
Гэвин Бэрри Уайлд
Разван Ханиф
Паж Кристофер Джон Ле
Original Assignee
Юсб Биофарма Спрл
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Юсб Биофарма Спрл filed Critical Юсб Биофарма Спрл
Publication of EA201792329A1 publication Critical patent/EA201792329A1/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/113General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure
    • C07K1/1133General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure by redox-reactions involving cystein/cystin side chains
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/113General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure
    • C07K1/1136General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure by reversible modification of the secondary, tertiary or quarternary structure, e.g. using denaturating or stabilising agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C323/00Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups
    • C07C323/10Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and singly-bound oxygen atoms bound to the same carbon skeleton
    • C07C323/11Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and singly-bound oxygen atoms bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C323/12Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and singly-bound oxygen atoms bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C323/00Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups
    • C07C323/23Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and nitrogen atoms, not being part of nitro or nitroso groups, bound to the same carbon skeleton
    • C07C323/24Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and nitrogen atoms, not being part of nitro or nitroso groups, bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C323/25Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and nitrogen atoms, not being part of nitro or nitroso groups, bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K5/00Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
    • C07K5/04Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
    • C07K5/12Cyclic peptides with only normal peptide bonds in the ring
    • C07K5/123Tripeptides

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

В настоящем изобретении предлагается способ увеличения процента мономера в композиции молекул рекомбинантно экспрессированного антитела, отличающийся тем, что молекула антитела содержит по меньшей мере один Fv со специфичностью к интересующему антигену, содержащий один VH и один VL, где указанные VH и VL связаны прямо или косвенно через один или несколько линкеров и стабилизируются дисульфидной связью между ними, причем указанный способ включает: a) стадию конверсии обработки композиции денатурирующим агентом, выбранным из мочевины и/или гидрохлорида гуанидина; b) где стадию a) проводят в присутствии восстанавливающего агента или после обработки восстанавливающим агентом.The present invention proposes a method of increasing the percentage of monomer in a composition of recombinantly expressed antibody molecules, characterized in that the antibody molecule contains at least one Fv with specificity for the antigen of interest, containing one VH and one VL, where said VH and VL are linked directly or indirectly through one or more linkers and are stabilized by a disulfide bond between them, and this method includes: a) the conversion stage of processing the composition with a denaturing agent selected from urea and / or g drohlorida guanidine; b) where stage a) is carried out in the presence of a reducing agent or after treatment with a reducing agent.

EA201792329A 2015-04-22 2016-04-22 METHOD OF MONOMERIZATION OF RECOMBINANT ANTIBODY MOLECULES EA201792329A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1506870.3A GB201506870D0 (en) 2015-04-22 2015-04-22 Method
PCT/EP2016/059051 WO2016170138A1 (en) 2015-04-22 2016-04-22 Method of monomerisation of recombinant antibody molecules

Publications (1)

Publication Number Publication Date
EA201792329A1 true EA201792329A1 (en) 2018-02-28

Family

ID=53299019

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201792329A EA201792329A1 (en) 2015-04-22 2016-04-22 METHOD OF MONOMERIZATION OF RECOMBINANT ANTIBODY MOLECULES

Country Status (17)

Country Link
US (2) US10828366B2 (en)
EP (1) EP3286204B1 (en)
JP (1) JP6898251B2 (en)
KR (1) KR20170138552A (en)
CN (1) CN108064230B (en)
AU (1) AU2016251620A1 (en)
BR (1) BR112017021812A2 (en)
CA (1) CA2981644C (en)
CL (1) CL2017002676A1 (en)
CO (1) CO2017010385A2 (en)
EA (1) EA201792329A1 (en)
ES (1) ES2846732T3 (en)
GB (1) GB201506870D0 (en)
IL (1) IL254765A0 (en)
MX (1) MX2017013376A (en)
SG (1) SG11201708151TA (en)
WO (1) WO2016170138A1 (en)

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Also Published As

Publication number Publication date
KR20170138552A (en) 2017-12-15
JP6898251B2 (en) 2021-07-07
AU2016251620A1 (en) 2017-10-26
EP3286204B1 (en) 2020-11-18
CL2017002676A1 (en) 2018-03-23
US11786593B2 (en) 2023-10-17
SG11201708151TA (en) 2017-11-29
CA2981644A1 (en) 2016-10-27
US20180117153A1 (en) 2018-05-03
JP2018515449A (en) 2018-06-14
EP3286204A1 (en) 2018-02-28
CN108064230B (en) 2021-04-06
GB201506870D0 (en) 2015-06-03
WO2016170138A1 (en) 2016-10-27
CO2017010385A2 (en) 2018-03-20
US20210069328A1 (en) 2021-03-11
IL254765A0 (en) 2017-12-31
US10828366B2 (en) 2020-11-10
CN108064230A (en) 2018-05-22
CA2981644C (en) 2023-07-04
MX2017013376A (en) 2017-12-07
BR112017021812A2 (en) 2018-07-10
ES2846732T3 (en) 2021-07-29

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